Evaluation of Safety and Effectiveness of the FMwand Ferromagnetic Surgical System During Parotidectomy Surgery

N/ACompletedNCT02291939

Domain Surgical, Inc.5 enrolled

Overview

The objective of the clinical trial is to determine the suitability of the FMwand Ferromagnetic Surgical System for parotidectomy and Head \& Neck surgery.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Parotid Diseases

Interventions

ParotidectomyPROCEDURE

Surgical Intervention with the FMwand Surgical System

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with an indication for surgical intervention for a parotidectomy. * ECOG status ≤ 2. * Life expectancy \> 3 months. * Age ≥ 18 years old. * Able to provide written informed consent and EU Data Protection Directive forms prior to admission to this study. * Willingness to meet all of the expected requirements of this clinical protocol. Exclusion Criteria: * Age \< 18 years old. * Pregnant or breastfeeding. * Vulnerable patient populations (homeless patients, patients with drug or alcohol dependence, etc.). * Concomitant treatments that would affect clotting, post-operative healing, increased chances of infection. * Previous radiation treatment * Previous head or neck surgery

Locations (1)

San Camillo-Forlanini Hospital

Roma, Italy

Outcomes

Primary Outcomes

Intraoperative Serious Adverse Events as a Measure of Safety and Feasibility

Safety and feasibility will be assessed by evaluating intra-operative serious adverse events, if any, and their relationship with the FMwand Ferromagnetic Surgical System.

Time frame: 1 day after surgery

Secondary Outcomes

Post-operative drainiage

Evaluation of Post-operative Drainage

Time frame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days

Swelling of surgical wound

Evaluation of surgical wound appearance based on swelling

Time frame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days

Necrosis of surgical margins

Serosity and necrosis of margins

Time frame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days

Length of hospital stay

Number of days (post-operative) of hospital stay

Time frame: Beginning day 2 after surgery and for the duration of hospital stay, an expected average of 6 days

Data from ClinicalTrials.gov

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